Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients
Recruiting
N/A
Interventional Study
Vaginal Dryness
Breast Cancer
Vulvovaginal Atrophy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 40 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 75 (estimated)
- Sponsor
- Centre Oscar Lambret · Other
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About This Trial
This Phase III, randomized, balanced, parallel-group, multicenter trial aims to evaluate the effect of vaginal radiofrequency on symptoms of vaginal dryness at six months. The study compares vaginal radiofrequency treatment with non-hormonal hydration therapy in a population of patients undergoing adjuvant hormonal therapy with aromatase inhibitors, with or without LHRH agonists, for breast cancer…
Trial Locations
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Eligibility Criteria
INCLUSION CRITERIA :
* Patient over 40 years
* Presenting disabling vaginal dryness symptoms despite well-administered local moisturizing treatment, attested by a vaginal dryness score ≥3
* Patient undergoing adjuvant treatment for breast cancer
* Patient treated with aromatase inhibitors +/- LHRH …
Contacts